Job Description

Santen is a specialized pharmaceutical company with a 130-year heritage focused exclusively on ophthalmology. With sales in over 60 countries, Santen’s 4,000 global employees work to deliver life-changing therapies that make hope a reality for people facing vision impairment and loss. Santen Inc., located in Emeryville, CA (North America HQ), serves as an important global research & development hub for the organization, and is home to about half of our North America employee population, which includes global manufacturing sites in Miami, Fl and Goleta, CA.

Santen InnFocus, Inc. in Miami is looking for a Complaint Coordinator to join their team. The role is 100% on-site.

This role focuses on managing and processing product complaints related to the PRESERFLO MicroShunt. You will play a key role in ensuring compliance with regulatory standards while supporting product quality and continuous improvement.

What you will do

Complaint Handling & Investigation

• Receive and process product returns
• Perform testing and documentation on returned devices
• Conduct root cause investigations using production/QC data
• Determine reportability (e.g., adverse events) with internal teams

Cross-functional & Global Collaboration

• Communicate with global Santen entities
• Work with clinical, regulatory, and technical teams
• Handle sensitive information with professionalism

Documentation & Systems

• Maintain complaint databases and files
• Ensure accurate and timely data entry
• Document outcomes, corrective actions, and feedback

Compliance & Quality

• Ensure adherence to:
  • ISO 13485
  • EU MDR
  • 21 CFR Part 820
• Support internal/external audits
• Contribute to continuous improvement

Qualifications

What you will bring to the role

• Bachelor’s degree or equivalent experience
• Minimum 5 years’ experience in the medical device industry
• Knowledge of ISO 13485, EUMDR, and 21 CFR Part 820
• Experience with complaint handling or returned goods preferred
• Strong MS Office skills (Word, Excel, PowerPoint, Outlook)
• Understanding of ophthalmic terminology is a plus
• Strong communication and organizational skills
• Fluent in English (written and spoken)

  What we offer:

  The salary range for the Compliant Coordinator position is $47,031- $70,547depending on experience.

Additional Information

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.